press releases
Cybrexa Therapeutics Receives Green Light from FDA on Investigational New Drug Application for CBX-12 (alphalex™-exatecan)
NEW HAVEN, Conn., March 22, 2021 (GLOBE NEWSWIRE) — Cybrexa Therapeutics, an oncology-focused biotechnology company developing a new class of therapeutics through its alphalex™ Peptide Drug Conjugate (PDC) tumor targeting platform, today announced that the U.S. Food and Drug Administration (FDA) has provided the green light regarding the Investigational New Drug (IND) application for CBX-12 (alphalex™-exatecan), the company’s lead therapeutic candidate.
“The go ahead from the FDA on our IND application for CBX-12 is a major step in the clinical development of what we believe could be a game-changing therapeutic for many cancer patients,” said Per Hellsund, President and CEO of Cybrexa. “Preclinical studies of CBX-12 show a strong efficacy and safety profile, and we expect that the Phase I clinical trial will help us learn more about the potential applications of this therapeutic candidate. The clinical development of CBX-12 is important, not just as we move toward bringing this candidate to market, but in expanding the addressable patient populations with therapeutics that target a broader scope of solid tumors, allowing us to treat a greater number of patients.”
CBX-12 is a novel treatment for solid tumors that includes a highly potent topoisomerase I inhibitor payload that is in the same class as the payloads used by antibody-drug conjugates (ADCs) ENHERTU® and TRODELVY™. In contrast to these ADCs, CBX-12 is able to target cancer cells independent of antigen expression, which could greatly expand the addressable patient populations. The positive results from the GLP toxicology study of CBX-12 will serve as a guide for dosing regimen for the planned Phase I trial of CBX-12, which Cybrexa plans to initiate in April 2021.
About the alphalex™ Technology Platform
The Cybrexa alphalex™ technology platform – which consists of a pHLIP® peptide, linker, and small molecule anti-cancer agent (payload) – enables antigen-independent targeting of tumors and intracellular delivery of highly potent anticancer therapies, creating therapeutics that can revolutionize the standard of care. pHLIP® peptides are a family of pH-Low Insertion Peptides that target acidic cell surfaces. pHLIP® was developed at Yale University and the University of Rhode Island, and is exclusively licensed to pHLIP, Inc. alphalex™ represents the disruptive next generation in tumor targeting. View a video of the mechanism of action of the technology at www.cybrexa.com.
About Cybrexa
Cybrexa is a privately-held biotechnology company dedicated to developing next-generation tumor-targeted cancer therapies using its alphalex™ platform. The Company’s lead candidate, CBX-12, an alphalex™-exatecan conjugate, is expected to enter Phase I/II in 2021 in advanced solid tumors. Cybrexa also has other preclinical toxin conjugate programs as well as synthetic lethality programs. Cybrexa was founded by physician-scientists and has an experienced management team that has built numerous successful life sciences companies. For more information about Cybrexa, please visit www.cybrexa.com.
Contacts
Cybrexa Therapeutics
Lisa Rehm
Email: [email protected]
Investor Relations
Stephanie Carrington
Tel: 646-277-1282
Email: [email protected]
Media Relations
Mark Corbae
Tel: 203-682-8288
Email: [email protected]
Cybrexa Therapeutics Closes $25 Million Series B Financing
Cybrexa Therapeutics Closes $25 Million Series B Financing
| Source: Cybrexa Therapeutics
-Proceeds will advance the company’s lead program into clinical trials-
NEW HAVEN, Conn., March 10, 2021 (GLOBE NEWSWIRE) — Cybrexa Therapeutics, an oncology-focused biotechnology company developing a new class of therapeutics through its alphalex™ Peptide Drug Conjugate (PDC) tumor targeting platform, today announced the completion of its $25 million Series B financing. The financing included HighCape Capital and new investor Elm Street Ventures. Proceeds from the financing will be used to support the planned advancement of Cybrexa’s lead candidate CBX-12 (alphalex™-exatecan) into the clinic. The first patient dosing in the Phase 1 study is expected in the first half of 2021.
“We are pleased that our efforts continue to be recognized and supported by our investors. This funding is a testament to our company’s progress, execution and the strength of our alphalex™ platform technology,” said Per Hellsund, President & CEO of Cybrexa. “This round of financing will be deployed to support the planned Phase 1 study for CBX-12.”
CBX-12 is a novel treatment for solid tumors that includes a highly potent topoisomerase I inhibitor payload that is in the same class as the payloads used by antibody-drug conjugates (ADCs) ENHERTU® and TRODELVY™. In contrast to these ADCs, CBX-12 is able to target cancer cells independent of antigen overexpression, which should greatly expand the addressable patient populations. The positive results from the GLP toxicology study of CBX-12 will serve as a guide for the dosing regimen in the planned Phase I trial.
“We believe Cybrexa’s technology and science form the basis for a robust development platform, capable of producing multiple targeted therapeutic options, for a variety of oncology indications,” said Kevin Rakin, Partner of HighCape Capital. “We see the progress of CBX-12 into human trials as a significant milestone for the platform, as well as providing even more opportunities from a business perspective.”
About CBX-12
CBX-12 is a novel treatment for solid tumors that includes a highly potent topoisomerase I inhibitor payload that is in the same class as the payloads used by antibody-drug conjugates (ADCs) ENHERTU® and TRODELVY™. In contrast to these ADCs, CBX-12 is able to target cancer cells independent of antigen overexpression, which should greatly expand the addressable patient populations. Positive results from the GLP toxicology study of CBX-12 will serve as a guide for dosing regimen for the planned Phase I trial of CBX-12, as Cybrexa filed the IND on February 19, 2021. CBX-12 is currently being investigated in collaboration with NCI in pre-clinical safety and efficacy studies in the solid tumor landscape. This partnership will also explore its therapeutic potential to conduct trials in a wide number of indications and in combination with other therapies such as immune-oncology and PARP inhibitors.
About the alphalex™ Technology Platform
The Cybrexa alphalex™ technology platform – which consists of a pHLIP® peptide, linker, and small molecule anti-cancer agent (payload) – enables antigen-independent targeting of tumors and intracellular delivery of highly potent anticancer therapies, creating therapeutics that can revolutionize the standard of care. pHLIP® peptides are a family of pH-Low Insertion Peptides that target acidic cell surfaces. pHLIP® was developed at Yale University and the University of Rhode Island, and is exclusively licensed to pHLIP, Inc. alphalex™ represents the disruptive next generation in tumor targeting. View a video of the mechanism of action of the technology at www.cybrexa.com.
About Cybrexa
Cybrexa is a privately-held biotechnology company dedicated to developing next-generation tumor-targeted cancer therapies using its alphalex™ platform. The Company’s lead candidate, CBX-12, an alphalex™-exatecan conjugate, is expected to enter Phase I/II in 2021 in advanced solid tumors. Cybrexa also has other preclinical toxin conjugate programs as well as synthetic lethality programs. Cybrexa was founded by physician-scientists and has an experienced management team that has built numerous successful life sciences companies. For more information about Cybrexa, please visit www.cybrexa.com.
Contacts
Cybrexa Therapeutics
Lisa Rehm
Email: [email protected]
Investor Relations
Stephanie Carrington
Tel: 646-277-1282
Email: [email protected]
Media Relations
Mark Corbae
Tel: 203-682-8288
Email: [email protected]
Cybrexa Therapeutics Enters Cooperative Research and Development Agreement (CRADA) with…
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Cybrexa Therapeutics Enters Cooperative Research and Development Agreement (CRADA) with U.S. National Cancer Institute to Develop CBX-12 (alphalex™- exatecan)
– Cybrexa and NCI to collaborate on clinical development of Cybrexa’s lead candidate, CBX-12, to assess the safety and efficacy in oncology patients with solid tumors –
NEW HAVEN, Conn., Feb. 24, 2021 (GLOBE NEWSWIRE) — Cybrexa Therapeutics, an oncology-focused biotechnology company developing a new class of therapeutics through its alphalex™ Peptide Drug Conjugate (PDC) tumor targeting platform, today announced that it has entered a Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI), part of the National Institutes of Health. Under terms of the agreement, Cybrexa and the NCI will collaborate on pre-clinical and potential clinical development of Cybrexa’s lead therapeutic candidate, CBX-12 (alphalex™-exatecan).
“This research and development agreement with the NCI is not only a validation of Cybrexa’s technology, but may also allow us to significantly expand our clinical development program,” said Per Hellsund, President and CEO of Cybrexa. “Collaborating with the NCI on the development of CBX-12 may allow testing of its therapeutic potential by some of the world’s leading oncology researchers. This collaboration also dramatically expands our ability to conduct clinical trials in a wide number of indications, and in combination with other therapies such as immuno-oncology and PARP inhibitors.”
Cybrexa and the NCI will work together initially focusing on pre-clinical studies and move on to clinical development of CBX-12, if the preclinical studies support clinical development, to demonstrate its safety and efficacy in patients with a variety of solid tumors.
CBX-12 is a novel treatment for solid tumors that includes a highly potent topoisomerase I inhibitor payload that is in the same class as the payloads used by antibody-drug conjugates (ADCs) ENHERTU® and TRODELVY™. In contrast to these ADCs, CBX-12 is able to target cancer cells independent of antigen overexpression, which should greatly expand the addressable patient populations. The positive results from the GLP toxicology study of CBX-12 will serve as a guide for dosing regimen for the planned Phase I trial of CBX-12, as Cybrexa filed the IND on February 19, 2021.
About the alphalex™ Technology Platform
The Cybrexa alphalex™ technology platform – which consists of a pHLIP® peptide, linker, and small molecule anti-cancer agent (payload) – enables antigen-independent targeting of tumors and intracellular delivery of highly potent anticancer therapies, creating therapeutics that can revolutionize the standard of care. pHLIP® peptides are a family of pH-Low Insertion Peptides that target acidic cell surfaces. pHLIP® was developed at Yale University and the University of Rhode Island, and is exclusively licensed to pHLIP, Inc. alphalex™ represents the disruptive next generation in tumor targeting. View a video of the mechanism of action of the technology at www.cybrexa.com.
About Cybrexa
Cybrexa is a privately-held biotechnology company dedicated to developing next-generation tumor-targeted cancer therapies using its alphalex™ platform. The Company’s lead candidate, CBX-12, an alphalex™-exatecan conjugate, is expected to enter Phase I/II in 2021 in advanced solid tumors. Cybrexa also has other preclinical toxin conjugate programs as well as synthetic lethality programs. Cybrexa was founded by physician-scientists and has an experienced management team that has built numerous successful life sciences companies. For more information about Cybrexa, please visit www.cybrexa.com.
Contacts
Cybrexa Therapeutics
Lisa Rehm
Email: [email protected]
Investor Relations
Stephanie Carrington
Tel: 646-277-1282
Email: [email protected]
Media Relations
Mark Corbae
Tel: 203-682-8288
Email: [email protected]